Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
53329–53352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2009
PULPDENT MICRO-HYBRID COMPOSITE
K090391 · EBF
Pulpdent Corporation
Dental · 83d
Cleared May 11, 2009
FSC 2
K090601 · NTN
Schoelly Imaging, Inc.
Gastroenterology & Urology · 67d
Cleared May 11, 2009
MONOBOND PLUS
K090826 · KLE
Ivoclar Vivadent, Inc.
Dental · 46d
Cleared May 11, 2009
POWER DRIVE CHAIR, MODEL: TMM6
K091043 · INK
Transmotion Medical, Inc.
Physical Medicine · 28d
Cleared May 11, 2009
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER,...
K091113 · INI
Pride Mobility Products Corp.
Physical Medicine · 24d
Cleared May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1,...
K081286 · MYA
Dako North America, Inc.
Pathology · 366d
Cleared May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · HAW
Brainlab AG
Neurology · 291d
Cleared May 08, 2009
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · GYC
Pmt Corp.
Neurology · 253d
Cleared May 08, 2009
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K083156 · LZA
Giga-Drive Sdn, Bhd
General Hospital · 196d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499 · OTP
Coloplast A/S
Obstetrics & Gynecology · 164d
Cleared May 08, 2009
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED),...
K083729 · GGW
Aniara Diagnostica, LLC
Hematology · 143d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K090078 · NXM
Iop, Inc.
Ophthalmic · 116d
Cleared May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
K090243 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 95d
Cleared May 08, 2009
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
K090338 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 87d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 84d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
K090409 · MXJ
Bio-Rad Laboratories
Microbiology · 79d
Cleared May 08, 2009
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · LYZ
Shandong Huayue Glove Co., Ltd.
General Hospital · 71d
Cleared May 08, 2009
SYNGO RT THERAPIST CONNECT
K090683 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 08, 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared May 08, 2009
FLEX-TENS
K090717 · GZJ
Emsi
Neurology · 51d
Cleared May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR...
K090864 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 39d
Cleared May 08, 2009
ACCUTORR V MONITOR, MODEL 0998-00-2000
K091068 · DXN
Datascope Corp., Patient Monitoring...
Cardiovascular · 24d
Cleared May 08, 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · KWQ
Nuvasive, Inc.
Orthopedic · 24d